Cleared Traditional

K990368 - DUODERM HYDROACTIVE GEL WOUND DRESSING

K990368 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
46d
Days
-
Risk

K990368 is an FDA 510(k) clearance for the DUODERM HYDROACTIVE GEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Convatec, A Bristol-Myers Squibb Co. (Skillman, US). The FDA issued a Cleared decision on March 26, 1999 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Convatec, A Bristol-Myers Squibb Co. devices

FDA 510(k) Submission Details - K990368

510(k) Number K990368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date March 26, 1999
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 16
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K990368.
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc. · Apr 2000
MODIFICATION TO WOUN'DRES
K991202 · Coloplast Corp. · Jun 1999
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
SWEEN WOUN'DRES
K983042 · Coloplast Corp. · Nov 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998